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Pulmonary toxicity was treated with supportive care (oxygen and assisted ventilation as necessary).
Any grade 1 toxicity was treated symptomatically and therapy was allowed to continue.
These were typically 1 × 1 mm across, as shown in Figure 2A and B. Skin toxicity was treated with cool-packs and aloe gel: grade 1 toxicity generally resolved by day 12 without further action.
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Any patient who required a pemetrexed dose reduction due to hematological or non-hematological toxicities was treated further according to dose reductions.
Nonhaematological grade 1 toxicities were treated as follows: diarrhoea-codeine phosphate 30 60 mg p.o. qds, stomatitis-sucralfate 1 g qds, and plantar-palmar erythema-pyridoxine 50 mg p.o. tds.
Two patients experienced Grade 3 late toxicity; one was treated with RRT (1/35, with CCT) and the other was treated with S + ART (1/5).
Two patients received cycle 1 at 24 mg m−2, without significant toxicity, so the next patient was treated with 36 mg m−2, but he experienced DLT.
In almost all current Phase I designs, toxicity response is treated coarsely as a binary indicator of dose limiting toxicity (DLT) and a lot of useful toxicity information is discarded.
Our novel toxicity scoring system and EID may help to begin a new era in which toxicity response is treated as a continuous variable.
Five patients experienced Grade 3 acute toxicity; two were treated with RRT (2/35), and three were treated with S + ART (3/5, 2 of them with CCT).
Among the five patients with Grade 3 acute toxicity, two were treated with RRT (2/35 patients, 5%) and three were treated with S + ART (3/5 patients, 60%).
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CEO of Professional Science Editing for Scientists @ prosciediting.com